US7959599B2 - Disposable injector with dual-piston dual-chamber system - Google Patents

Disposable injector with dual-piston dual-chamber system Download PDF

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Publication number
US7959599B2
US7959599B2 US12/802,033 US80203310A US7959599B2 US 7959599 B2 US7959599 B2 US 7959599B2 US 80203310 A US80203310 A US 80203310A US 7959599 B2 US7959599 B2 US 7959599B2
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United States
Prior art keywords
cylinder
piston
piston unit
injector
disposable injector
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Expired - Fee Related
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US12/802,033
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English (en)
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US20100249697A1 (en
Inventor
Rudolf Matusch
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LTS Lohmann Therapie Systeme AG
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LTS Lohmann Therapie Systeme AG
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Assigned to LTS LOHMANN THERAPIE-SYSTEME AG reassignment LTS LOHMANN THERAPIE-SYSTEME AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MATUSCH, RUDOLF
Publication of US20100249697A1 publication Critical patent/US20100249697A1/en
Priority to US13/066,257 priority Critical patent/US8211086B2/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/1782—Devices aiding filling of syringes in situ
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion

Definitions

  • the invention relates to a disposable injector with a housing, an injector-side, first cylinder-piston unit—at least intermittently fillable—arranged therein and an upstream detachable container adapter of the latter, wherein the container adapter bears a likewise at least intermittently fillable second cylinder-piston unit.
  • WO 96/19252 discloses a system with two cylinder-piston units designed for an injector.
  • the injector-side, first cylinder-piston unit stores the active ingredient, while the upstream second cylinder-piston unit is filled with a solvent.
  • the solvent is pumped into the injector-side cylinder-piston unit to make the solution.
  • the container adapter is separated from the injector.
  • the aim of the present invention is to develop a modular constructed disposable injector which in each case separately and sterilely stores liquid and an active ingredient and has a space in which the active ingredient for the application is dissolved in the liquid or is mixed with the liquid.
  • the invention relates to a disposable injector with a housing, an injector-side, first cylinder-piston unit—at least intermittently fillable—arranged thereon and an upstream detachable container adapter, wherein the container adapter bears a likewise at least intermittently fillable second cylinder-piston unit.
  • a solvent is stored in the first cylinder-piston unit.
  • the second cylinder-piston unit there is a freeze-dried active pharmaceutical ingredient.
  • the solvent is conveyed to the second cylinder-piston unit to the active pharmaceutical ingredient, where a solution forms. This solution is transfer-pumped into the first cylinder-piston unit to then be administered.
  • the present invention develops a disposable injector which stores a liquid and an active ingredient in each case separately and sterilely and provides a space in which the active ingredient is dissolved for application in the liquid or mixed with the liquid.
  • the piston of the first cylinder-piston unit is movably arranged in a suction- and pressure-controlled manner in a cylinder sealed at the back in the delivery state.
  • the container adapter is attached detachably to the disposable injector via a coupling element, in which it is arranged to displaceable longitudinally.
  • the container adapter has an adapter region and a container region, whereby both regions are separated by an intermediate floor with throughhole. Between the intermediate floor and the injector-side cylinder sits a needle holder closely adjacent in the region of the front abutting face of the injector-side cylinder and having an injection needle.
  • the second cylinder-piston unit is arranged at the back, and is tightly sealed on the front side—in the delivery state—with an elastic stopper and on the rear side with a piston secured detachably against running in.
  • the tip of the injection needle terminates sealed in the stopper.
  • the container adapter is mounted displaceably against the needle holder in the coupling element to make a hydraulic connection between the interior space of the injector-side cylinder and the interior space of the other cylinder.
  • the solvent is stored in an injector-side, first cylinder-piston unit, while the active ingredient is contained in second cylinder-piston unit under vacuum, upstream of the cylinder-piston unit.
  • An injection needle, which is sealed on the second cylinder-piston unit is arranged temporarily in front of the first cylinder-piston unit.
  • the solvent flows over into the interior space of the second cylinder-piston unit and dissolves the active ingredient there to form the solution.
  • the solution is pumped into the first cylinder-piston unit with the piston of the second cylinder-piston unit.
  • the piston of the second cylinder-piston unit is pushed at least 80% into the cylinder.
  • the piston of the second cylinder-piston unit is drawn back to generate negative pressure. If required, it can be locked in its end position, holding a residual negative pressure. The locking is released by previous push-in actuation of the piston to convey the solution into the interior space of the first cylinder-piston unit.
  • the invention here for example presents a needle-free disposable injector which comprises two cylinder-piston units.
  • a first cylinder-piston unit is integrated in the injector and a second is arranged removably and spatially in front of the injector-side spray nozzle.
  • a solvent e.g. water for infusion purposes
  • the second cylinder-piston unit is e.g. a likewise sterile packed, freeze-dried active pharmaceutical ingredient.
  • the water is conveyed into the second cylinder-piston unit to the active pharmaceutical ingredient, where a solution, a suspension or an emulsion forms.
  • This liquid is transfer-pumped into the first cylinder-piston unit to then be able to be injected. No lumps enter the cylinder space of the first cylinder-piston unit during transfer-pumping, guaranteeing a precise injection stream.
  • the second cylinder-piston unit is placed hydraulically upstream of the first cylinder-piston unit. According to the embodiment it sits spatially in front of the first cylinder-piston unit.
  • the second cylinder-piston unit can however also be arranged to the side of the injector. In this case, e.g. both cylinder-piston units lie parallel next to one another.
  • FIG. 1 illustrates a disposable injector with two compression bars and conical collar area
  • FIG. 2 is a sectional enlargement of FIG. 1 ;
  • FIG. 3 is a sectional enlargement of FIG. 1 , however angularly offset by 90 degrees;
  • FIG. 4 is a sectional enlargement of FIG. 1 , the injector-side cylinder interior stores solvent, and the external cylinder space stores a lyophilate;
  • FIG. 5 is as for FIG. 4 , however the solution of solvent and lyophilate is in the external cylinder interior;
  • FIG. 6 is as for FIG. 4 , however the solution is in the injector-side cylinder interior;
  • FIG. 7 is as for FIG. 1 , however unlocked and actuated;
  • FIG. 8 is as for FIG. 2 , however after medicament ejection.
  • FIGS. 7 and 8 show a disposable injector with a housing ( 10 ), in which or on which—in each case at least in certain areas—at least one mechanical spring-loaded energy store, at least one—at least intermittently fillable with active ingredient—cylinder-piston unit ( 100 ), at least one piston-actuating plunger ( 60 ) and at least one triggering unit ( 80 ) is arranged, whereby the spring-loaded energy store ( 50 ) comprises at least one pre-tensed spring element, whereby at least part of the piston-actuating plunger ( 60 ) is positioned between the spring-loaded energy store ( 50 ) and the piston ( 111 ) of the cylinder-piston unit ( 100 ).
  • a removable container adapter ( 200 ) which likewise stores an at least intermittently fillable cylinder-piston unit ( 250 ), is arranged spatially in front of the housing ( 10 ) and in front of the cylinder-piston unit ( 100 ).
  • the single-part housing ( 10 ) of the needle-free injector is a pot-shaped hollow body open to the bottom with elevated floor ( 39 ), as in FIG. 7 , and is made from e.g. glassfibre-reinforced polyamide by injection moulding.
  • the housing ( 10 ) is subdivided into two functional areas, that is, on the one hand the upper mantle area ( 31 ) and on the other hand the lower fixing area ( 41 ).
  • the housing ( 10 ) has e.g. two opposite windowlike openings ( 33 ), as in FIG. 1 .
  • On the lower edge of the individual opening ( 33 ) a compression bar ( 21 ) is respectively mounted articulated.
  • the compression bars ( 21 ) are formed onto the housing ( 10 ) and spring outwards as elastic flexional beams ( 28 ).
  • the forming site of the compression bars ( 21 ) is just above the fixing area ( 41 ).
  • a narrow, at least approximately U-shaped gap which encloses the individual compression bar to the side and top is in the mantle section ( 31 ) for forming the respective compression bars ( 21 ).
  • Over approx. 80% of its length the compression bar ( 21 ) has the wall thickness and curve of the walls of the housing ( 10 ). In particular, this region also has i.a. the function of the spring-elastic flexional beam ( 28 ) and has a sickle-shaped cross-section.
  • part of this flexional beam ( 28 ) can also be equipped with a rectangular cross-section to reduce flexural stresses occurring during use in the flexional beam edge region.
  • the compression bar ( 21 ) is shown in the undeformed state.
  • the upper free end here of the individual compression bar ( 21 ) is formed by the radially outwards projecting cam ( 22 ) which has at least one support surface ( 23 ) and one radial bearing face ( 24 ).
  • the plunger plate ( 73 ) of the tensioned disposable injector lies on the support surface ( 23 ) via its collar surface ( 75 ).
  • the support surface ( 23 ), which here fulfills the function of a wedge face, has the form of a frustum mantle with a tip angle of 120 degrees.
  • the compression bars ( 21 ) or the collar surface ( 75 ) at least in the contact area have ceramic armouring or are reinforced e.g. by a stuck-on frustum-mantle-shaped washer.
  • the bearing surface ( 24 ) of the cams ( 22 ) of the undeformed flexional beams ( 28 ) is part of a frustum mantle, whereof the maximal diameter is e.g. 3 to 4 millimetres greater than the outer diameter of the housing ( 10 ), as in FIG. 8 .
  • the bearing surface ( 24 ) contacts the inner walls ( 59 ) of the sleeve-like trigger element ( 82 ).
  • the bearing surface ( 24 ) has a curve which corresponds to the inner walls ( 59 ) for minimizing the surface pressing, if required.
  • the fixing area ( 41 ) for accommodating the incorporable cylinder-piston unit ( 100 ).
  • the fixing area ( 41 ) includes e.g. eight spring hooks ( 42 ) aligned parallel to the centre line ( 5 ).
  • the spring hooks ( 42 ) in each case have an at least two-flank back grip ( 43 ) for play-free receiving of the cylinder-piston unit ( 100 ).
  • the opposite flanks of the back grip ( 43 ) enclose an angle of e.g. 90 degrees of angle.
  • the length and the spring rate of the spring hooks ( 42 ) are such that the cylinder ( 101 ) can be incorporated without plastic deformation of the spring hooks ( 42 ).
  • the cylinder-piston unit ( 100 ) comprises a cylinder ( 101 ) filled with a liquid solvent ( 1 ), as in FIG. 1 , in which a piston ( 111 ) sits in the rear position.
  • a piston ( 111 ) sits in the rear position.
  • the piston-actuating plunger ( 60 ) is arranged e.g. such that it does not touch the piston, however is guided to the side by its lower end into the upper region of the cylinder ( 101 ).
  • the cylinder ( 101 ) is e.g. a transparent, thick-walled pot, whereof the cylindrical outer wall bears a for example circumferential detent rib ( 102 ), if required, as in FIG. 7 , which lies dimensionally stably on the flanks of the back grip ( 43 ) of the spring hooks ( 42 ).
  • the rod-less piston ( 111 ) In the for example cylindrical bore of the cylinder ( 101 ) sits the rod-less piston ( 111 ).
  • the piston ( 111 ) has on its front, at least approximately conically configured abutting face an axial annular groove ( 112 ) for taking up a sealing ring ( 114 ) or a permanently elastic sealing mass.
  • Set into the rear abutting face of the piston ( 111 ) if required is an e.g. cylindrical metal plate.
  • a short cylindrical, nozzle-like bore ( 106 ) In the centre of the bore of the cylinder ( 101 ), whereof the cylinder floor 108 at least approximately matches the contour of the front piston front end, is a short cylindrical, nozzle-like bore ( 106 ). Its diameter is approx. 0.1 to 0.5 millimetre. This bore ( 106 ) is one to five times as long as its diameter. It terminates in a cylindrical recess ( 107 ) of the floor-side outer abutting face ( 103 ) of the cylinder ( 101 ). This abutting face ( 103 ) can be provided with an adhesive ring ( 104 ) to additionally boost application safety.
  • the cylinder ( 101 ) is sealed sterile on the rear side with a sterile filter membrane ( 119 ).
  • the helical compression spring ( 50 ) sits pre-tensioned.
  • the resilient force is transferred via the plunger plate ( 73 ) to the compression bars ( 21 ). Due to the inclination of the collar surface ( 75 ) the compression bars ( 21 ) are forced radially outwards in the manner of a bevel gear.
  • the outer sleeve ( 82 ) permanently supports this radial force.
  • the piston-actuating plunger ( 60 ) has a pilot pin ( 62 ) above the plunger plate ( 73 ) which pin guides the helical compression spring ( 50 ). Underneath the plunger plate ( 73 ) centrally in the extension of the pilot pin ( 62 ) is the piston slide valve ( 76 ) which acts on the piston ( 111 ) when the disposable injector is activated. In the embodiment the piston slide valve ( 76 ) terminates e.g. 2 to 4 millimetres above the sterile filter membrane ( 119 ) of the cylinder-piston unit ( 100 ).
  • the plunger plate ( 73 ) is a flat disc, cylindrical at least in certain areas, the outer diameter of which is a few tenths of a millimetre smaller than the inner diameter of the housing ( 10 ) in the mantle area ( 31 ).
  • the lower front end has a collar surface ( 75 ) arranged around the piston slide valve ( 76 ). It has the form of a frustum mantle, whose apex angle is about 100 to 130, preferably 120 degrees. The notional tip of the frustum mantle lies on the centre line ( 5 ) in the region of the piston slide valve ( 76 ).
  • the collar surface ( 75 ) can also be curved spherically.
  • the piston slide valve ( 76 ) can of course also be designed as a component separate from the plunger plate ( 73 ). For this it is then guided on the inner walls of the housing ( 10 ).
  • just a single compression bar ( 21 ) also can be used in place of two or more compression bars ( 21 ).
  • FIGS. 1 , 7 and 8 The figures illustrate a compression bar-injector with a trigger unit ( 80 ) almost fully surrounding the housing ( 10 ). Attached to the trigger element ( 82 ) is a release cap ( 81 ) which encloses the back end of the housing ( 10 ), as in also FIGS. 1 , 7 and 8 .
  • the trigger element ( 82 ) partially enclosing the housing ( 10 ) and the cylinder-piston unit ( 100 ) is a release sleeve.
  • the transition between the for example cylindrical inner walls of the trigger element ( 82 ) and the return flank ( 84 ) is designed e.g. as a sharp edge ( 85 ).
  • the grooves ( 57 ) have e.g. comparatively the same distances and extend over 10 to 30 millimetres in length of the trigger element ( 82 ).
  • the release cap ( 81 ) is pushed by the back end of the trigger element ( 82 ).
  • a widened section ( 83 ) Directly above the return flank ( 84 ) of the trigger element ( 82 ) is a widened section ( 83 ).
  • this widened section ( 83 ) is positioned and dimensioned precisely such that it can take up the compression bars ( 21 ) forced outwards and retreating from the trigger procedure with their cams ( 22 ), as in FIG. 8 .
  • the inner contour of the widened section ( 83 ) is e.g. a circumferential channel.
  • the cams ( 22 ) lie with their outerlying bearing surfaces ( 24 ) on the inner walls ( 59 ) of the trigger element ( 82 ) as a security.
  • the release cap ( 81 ) lies slidably on the outer wall ( 13 ) of the housing ( 10 ).
  • the trigger element ( 82 ) has for example an annular groove ( 56 ), in which a circulating web or snap-in cams ( 55 ) of the release cap ( 81 ) engage.
  • the release cap ( 81 ) can be slit lengthways e.g. twice in certain areas, as in FIGS. 7 and 8 .
  • the release cap ( 81 ) has a depressed cap floor ( 86 ).
  • Several inwards projecting snap-in pins ( 87 ) are formed on the cap floor ( 86 ) about a centric bore, for example.
  • the snap-in pins ( 87 ) have tab notches ( 88 ) which grip round the edge of a central bore ( 38 ) of the housing floor ( 39 ).
  • the snap-in pins ( 87 ) are fixed by a pawl ( 131 ) of a push-button safety device ( 130 ), as in FIG. 2 , in the position gripping round the floor ( 39 ) in certain areas so that the release cap ( 81 ) can move in a longitudinal direction in combination with the trigger element ( 82 ) not opposite the housing ( 10 ).
  • the pawl ( 131 ) has an elastic, partly calotte-shaped pawl head ( 132 ), on which a pawl bolt ( 133 ) is formed. The latter bears at its lower, free end a blocking collar ( 134 ), which is set down against a waist ( 135 ). The blocking collar ( 134 ) holds the snap-in pins ( 87 ) in their locking position, as in FIG. 2 , and latches securely behind a detent link ( 136 ).
  • the spring-elastic snap-in pins ( 87 ) spring behind the blocking collar ( 134 ) and are placed on the waist ( 135 ).
  • the pawl ( 131 ) remains permanently in its actuated position, as in FIG. 8 .
  • the new sleeve area of the snap-in pins ( 87 ) now has an outer diameter which is smaller than the inner diameter of the bore ( 38 ). As a result, the mechanical coupling between the trigger element ( 82 ) and the housing ( 10 ) is freed.
  • the housing ( 10 ) has a lenticular elevation ( 16 ), as in FIG. 3 , via which the housing ( 10 ) rests on the edge ( 85 ) of the trigger element ( 82 ) for fixing the housing ( 10 ) securely together with the spring element ( 50 ) and the piston-actuating plunger ( 60 ) during installation in the trigger element ( 82 ).
  • the support rods ( 21 ) have cams ( 22 ) with particular back grip flanks ( 25 ).
  • These back grip flanks ( 25 ) lie at least approximately in a plane normal to the centre line ( 5 ) when the support rods ( 21 ) are deformed. Accordingly they latch abruptly over the edge ( 85 ) when the injector is released. After release they also lie firmly latched on the return flank ( 85 ) of the trigger element ( 82 ).
  • the e.g. cylindrical tubular coupling element ( 230 ) sheathes the cylinder ( 101 ) not only in certain areas and at the same time lies on the trigger element ( 82 ), but is also supported on the housing ( 10 ). For this it has in the vicinity of the abutting face ( 231 ) several bearing links ( 232 ) arranged on the inner wall.
  • the contact links ( 232 ) projecting radially inwards are aligned parallel to the centre line ( 5 ) and contact the spring hooks ( 42 ) of the housing ( 10 ).
  • the coupling element ( 230 ) has two opposite windows ( 236 ).
  • the windows ( 236 ) have a width which corresponds to at least the diameter of the piston ( 111 ).
  • the window centres are located at the level of the cylinder floor ( 108 ), as in FIG. 6 .
  • the inner wall of the coupling element ( 230 ) is substantially cylindrical and smooth, forming the guide surface for the container adapter ( 200 ).
  • In the guide surface if required is a long link parallel to the centre line ( 5 ) and not illustrated here, which engages in a corresponding groove of the container adapter ( 200 ) for preventing rotation.
  • the container adapter ( 200 ) is a boxlike component housing a cylinder-piston unit ( 250 ) in a container region ( 221 ). At the same time it has a sleeve-like adapter region ( 201 ) with which it sits longitudinally displaceable in the coupling element ( 230 ). On the inside the adapter region ( 201 ) guides a needle holder ( 240 ) in a longitudinally displaceable manner.
  • the adapter region ( 201 ) is a cylindrical beaker which surrounds the lower fifth of the cylinder ( 101 ) with clearance at least according to FIG. 4 . It has two opposing e.g. circular windows ( 206 ), as in FIG. 5 , several, e.g. four stop knobs ( 203 ) distributed over the periphery as upper stops for the needle holder ( 240 ) and an annular heel ( 204 ) on the centrally bored intermediate floor ( 211 ).
  • the windows ( 206 ) and the previously mentioned longitudinal link of the coupling element ( 230 ) can be omitted if the container adapter material is transparent.
  • the longitudinal link can also be omitted if the windows ( 206 ) have on the one hand a rectangular form and on the other hand several windows ( 206 ) separated from one another only by narrow links are distributed over the periphery.
  • the adapter region ( 201 ) On its outer wall the adapter region ( 201 ) has at the level of the intermediate floors ( 211 ) a circumferential notch ( 207 ), in which the latch knobs ( 237 ) engage, as per FIG. 4 .
  • the needle holder ( 240 ) is arranged directly in front of the adhesive foil ( 104 ) in front of the front end ( 103 ) of the cylinder ( 101 ).
  • the latter has a trunnion ( 241 ), with which it sits sealingly in the cylinder recess ( 107 ).
  • the lower outer edge of the needle holder ( 240 ) lies on the stop knobs ( 203 ).
  • a short injection needle ( 242 ) sticks centrally, e.g. encapsulated or adhered, into the cylindrical discoid needle holder ( 240 ).
  • the injection needle ( 242 ) projects right through the bore ( 212 ) of the e.g. planar intermediate floor ( 211 ) and terminates with its needle tip ( 243 ) e.g. in the middle in a stopper ( 257 ) laid under the intermediate floor ( 211 ).
  • the container region ( 221 ) there are likewise two or four opposite windows ( 226 ).
  • the outer wall has a circumferential notch ( 227 ), into which the latch knobs ( 237 ) of the coupling element ( 230 ) snap, as per FIG. 5 .
  • the container region ( 221 ) has on the lower end of its outer wall two grip elements, e.g. in the form of a cylinder grip plate standardized according to DIN 13098 part 2.
  • the cylinder-piston unit ( 250 ) is arranged in the container region ( 221 ). Its outer diameter is only slightly smaller than the inner diameter of the container region ( 221 ). The cylinder-piston unit ( 250 ) is e.g. stuck in the container region ( 221 ).
  • the cylinder-piston unit ( 250 ) has a cylinder which is formed from a transparent tube ( 251 ), e.g. a glass or plastic tube (COC), and an elastic stopper ( 257 ).
  • the stopper ( 257 ) lies at the top, has a flange edge ( 258 ), via which it rests axially on the glass tube ( 251 ).
  • the stopper ( 257 ) has asymmetrical notching ( 259 ) which if required is necessary for freeze-drying of the solution of the active pharmaceutical ingredient ( 2 ), e.g. a protein, contained in the cylinder-piston unit ( 250 ).
  • the glass tube ( 251 ) is sealed on the rear with a mobile piston ( 261 ).
  • the piston ( 261 ) comprises a piston rod ( 262 ), a rear piston pressure plate ( 264 ), a front stopper bearer ( 263 ) and an elastic piston stopper ( 267 ) set on it.
  • the piston ( 261 ) additionally has two or more latching elements ( 265 ) which are formed e.g. on the piston pressure plate ( 264 ) and are supported—springing elastically outwards—on the rear edge of the glass tube ( 251 ).
  • An elastic rubber ring ( 268 ) which presses the latching elements ( 265 ) outwards sits on the rear side of the piston stopper ( 267 ).
  • the piston pressure plate ( 264 ) In the direction of the glass tube ( 251 ) the piston pressure plate ( 264 ) has a cylindrical collar ( 266 ) having the same outer diameter as the container area ( 221 ).
  • the container region ( 221 ) and the piston ( 261 ) between the coupling element ( 230 ) and the piston pressure plate ( 264 ) is pasted over with a peel-off wrapper ( 280 ).
  • the peel-off wrapper ( 280 ) protectively covers the windows ( 226 ) and the latching elements ( 265 ) of the piston ( 261 ).
  • the tear-off foil ( 280 ) prevents unintentional pushing of the container adapter ( 200 ) into the coupling element ( 230 ).
  • the wrapper ( 90 ) an originality closure designed as adhesive label, covers almost the entire cylindrical outer wall of the coupling element ( 230 ) and the grooves ( 57 ) of the trigger element ( 82 ).
  • the wrapper ( 90 ) itself is e.g. a paper and/or film strip coated with an adhesive coated on one side in certain areas.
  • the wrapper ( 90 ) comprises three separate strips, which in each case can be separated from each other along a perforation ( 96 ) or via another predetermined breaking point.
  • the respectively circumferential perforations ( 96 ) lie above the grooves ( 57 ) and under the windows ( 206 ).
  • the top strip is a rear edge part ( 92 )
  • the middle strip is a tear-off wrapper ( 94 ) with a two- to three-centimetre-long tear-off tab ( 95 )
  • the lower strip is a frontal edge part ( 93 ). If the tear-off tab ( 95 ) and the tear-off wrapper ( 94 ) are unwrapped right around from the trigger element ( 82 ) and the coupling element ( 230 ) against the adhesion by separating the perforations ( 96 ), the coupling element ( 230 ) is still held on the injector only via clamping strength.
  • the active ingredient ( 2 ) e.g. a lyophilate stored in the cylinder-piston unit ( 250 )
  • the liquid ( 1 ) e.g. water for injection purposes, or physiological common salt solution, present in the cylinder ( 101 ) of the cylinder-piston unit ( 100 ).
  • the liquid ( 1 ) is to be pumped into the container ( 250 ).
  • the peel-off wrapper ( 280 ) is removed from the container region ( 221 ) and the container adapter ( 200 ) is pushed into the coupling element ( 230 ), as in FIG. 5 .
  • the injection needle ( 242 ) is pressed through the stopper ( 257 ) such that the needle tip ( 243 ) ends up in the cylinder interior ( 252 ).
  • the advance motion of the container adapter ( 200 ) is completed when the heel ( 204 ) is resting on the needle holder ( 240 ).
  • the windows ( 206 ) of the container adapter ( 200 ) are covered over by the windows ( 236 ) of the coupling element ( 230 ).
  • the latch knobs ( 237 ) latch in the circumferential notch ( 227 ).
  • the injection needle ( 242 ) Through penetration of the injection needle ( 242 ) into the cylinder interior ( 252 ) the latter communicates via the injection needle ( 242 ) with the cylinder interior ( 110 ).
  • the vacuum of the cylinder interior ( 252 ) sucks the liquid out of cylinder ( 101 ) of the cylinder-piston unit ( 100 ).
  • the suctioned piston ( 111 ) can follow the liquid ( 1 ) and comes to rest on the cylindrical floor ( 108 ).
  • the lyophilate ( 2 ) dissolves in the liquid ( 1 ). The dissolution procedure can be observed via the windows ( 226 ).
  • the tear-off wrapper ( 94 ) is removed.
  • the grooves ( 57 ) of the trigger element ( 82 ) thus become visible.
  • the injector is positioned such that the cylinder-piston unit ( 100 ) lies under the cylinder-piston unit ( 250 ), as in FIG. 6 .
  • the resulting solution ( 3 ) can pumped through the injection needle ( 242 ) into the cylinder interior ( 110 ).
  • the piston ( 261 ) is first released by the latching elements ( 265 ) being pressed in radially. Due to the residual vacuum the piston stopper ( 267 ) is placed on the surface of the solution ( 3 ).
  • the coupling element ( 230 ) is removed up off the housing ( 10 ) along with the container adapter ( 200 )—with reference to FIG. 6 .
  • the injector still remains secured.
  • the pawl head ( 132 ) After setting the injector onto the injection site in a last step, e.g. with the thumb of the hand holding the injector, the pawl head ( 132 ) must be pressed to move the trigger element ( 82 ) together with the release cap ( 81 ).
  • the trigger element ( 82 ) can now be pushed in the direction of the cylinder-piston unit ( 100 ). In this procedure the trigger element ( 82 ) glides on the outer wall ( 13 ) of the housing ( 10 ) linearly down, therefore in the direction of the injection site.
  • the bearing surfaces ( 24 ) of the compression bars ( 21 ) slip over the edge ( 85 ) and under the force of the spring element ( 50 ) are released to spring radially outwards into the widened section ( 83 ).
  • the compression bars ( 21 ) have bent elastically outwards and are now in their actual start position.
  • the now no longer deformed compression bars ( 21 ) release the piston-actuating plunger ( 60 ) so that the piston slide valve ( 76 ) moves abruptly towards the sterile filter membrane ( 119 ) of the cylinder ( 101 ) under the effect of the spring element ( 50 ).
  • the sterile filter membrane ( 119 ) is smashed and the piston ( 111 ) moves down to empty the cylinder ( 101 ), as in FIG. 8 .
  • the cylinder ( 100 ) is emptied.
  • a helical motion can also be provided.
  • the trigger element ( 82 ) and the housing ( 10 ) are guided to one another e.g. via a slide block and a connecting link.
  • release can also be effected by pure swivelling motion between the housing ( 10 ) and the trigger element ( 82 ).
  • the swivelling axis here would be the centre line ( 5 ).
  • the individual contact zone between the compression bar ( 21 ) and the plunger plate ( 73 ) is configured as surfaces ( 23 ) and ( 75 ) which contact each other with a gliding quality.
  • a roller can be mounted in each face ( 23 ) of the individual compression bars ( 21 ), which rolls away mounted on an anti-friction bearing, therefore without friction, when the injector is actuated on the face ( 75 ) of the plunger plates.
US12/802,033 2008-01-01 2010-05-29 Disposable injector with dual-piston dual-chamber system Expired - Fee Related US7959599B2 (en)

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DE102008003103 2008-01-01
DE102008003103.8 2008-01-01
DE200810003103 DE102008003103A1 (de) 2008-01-01 2008-01-01 Einweginjektor mit zweikolbigem Zweikammersystem
PCT/EP2008/010250 WO2009083089A1 (de) 2008-01-01 2008-12-04 Einweginjektor mit zweikolbigem zweikammersystem

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WO2022015491A1 (en) 2020-07-16 2022-01-20 Exxonmobil Chemical Patents Inc. Method of synthesizing a molecular sieve of mww framework type
WO2022184759A1 (en) 2021-03-03 2022-09-09 Exxonmobil Chemical Patents Inc. Method of synthesizing a molecular sieve of mww framework type

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EP2797681B1 (de) * 2011-12-29 2017-02-01 Omrix Biopharmaceuticals Ltd. Verfahren und vorrichtung zur schnellen auflösung von festen proteinzusammensetzung
US11077965B2 (en) * 2013-07-03 2021-08-03 Deka Products Limited Partnership Apparatus, system and method for fluid delivery
US10994871B2 (en) * 2013-07-03 2021-05-04 Deka Products Limited Partnership Apparatus, system and method for fluid delivery
JP6580777B2 (ja) 2015-08-13 2019-09-25 ウィンドギャップ メディカル， インコーポレイテッド 無菌特徴を有する混合及び注入装置
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US10239052B2 (en) 2014-01-27 2019-03-26 Exxonmobil Chemical Patents Inc. Synthesis of molecular sieves having MWW framework structure
US10940467B2 (en) 2014-01-27 2021-03-09 Exxonmobil Chemical Patents Inc. Synthesis of molecular sieves having MWW framework structure
WO2022015491A1 (en) 2020-07-16 2022-01-20 Exxonmobil Chemical Patents Inc. Method of synthesizing a molecular sieve of mww framework type
WO2022184759A1 (en) 2021-03-03 2022-09-09 Exxonmobil Chemical Patents Inc. Method of synthesizing a molecular sieve of mww framework type

Also Published As

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TW200942285A (en) 2009-10-16
EP2229202A1 (de) 2010-09-22
EP2229202B1 (de) 2013-11-06
ES2436147T3 (es) 2013-12-27
US20100249697A1 (en) 2010-09-30
DE102008003103A1 (de) 2009-07-02
WO2009083089A1 (de) 2009-07-09
JP5620274B2 (ja) 2014-11-05
JP2011508639A (ja) 2011-03-17
US20110196342A1 (en) 2011-08-11
US8211086B2 (en) 2012-07-03
AR070052A1 (es) 2010-03-10

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